NCT01699412

Clinical Trial With Clobetasol and Dexamethasone for Topical Treatment of Oral Lesions of Chronic Graft-versus-host Disease

Randomized Double-blid Clinical Trial Comparing the Topical Treatment With Clobetasol and Dexamethasone for Oral Lesions of Chronic Graft-versus-host Disease in Allogeneic Hematopoietic Stem Cell Transplant Recipients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Grupo de Estudos Multicentricos em Onco-Hematologia · Network
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to perform a randomized, double-blind, clinical trial comparing the topical treatment with clobetasol or dexamethasone for symptomatic oral lesions of chronic graft-versus-host disease.

Detailed description

All patients with symptomatic oral lesions of cGVHD were included in the study. Exclusion criteria were patients with 12 years or less of age, history of allergy to any of the studied medications and patients already under other topical treatment for oral lesions of cGVHD. Patients were randomly assigned between two study groups: one group rinsed with a solution of clobetasol propionate 0.05% associated to nystatin 100,000 UI/mL; and another group rinsed with a solution of dexamethasone 0.1 mg/ml associated to nystatin 100,000 UI/mL. Patients were instructed to use the solution 3 times a day, during 1 minute, for 28 days. Clinical exams were performed at baseline and after 28 days. Patients were evaluated by an oral medicine expert, previously calibrated for evaluation of oral cGVHD lesions. Oral lesions of cGVHD were diagnosed according to NIH 2005 criteria, and graded according to the modified oral mucositis rating scale. Evaluation of the symptoms of the oral mucosa and of xerostomia were performed through visual analogue scale. Samples for fungal culture were obtained before and after the topical treatment. Results were submitted to a descriptive analysis. Chi-square was used for the comparison of categorical variables. Mann-Whitney and Wilcoxon tests were used for the comparison of measurable data inter and intra-groups, respectively. Significance level was set at 5%.

Conditions

• Graft vs Host Disease
• Oral Manifestations

Interventions

Type	Name	Description
DRUG	Clobetasol	Rinse with a solution of clobetasol 0.05% associated to nystatin 100,000 UI/mL, for 1 minute, during 28 days
DRUG	Dexamethasone	Rinse with a solution of dexamethasone 0.1 mg/mL associated to nystatin 100,000 UI/mL, for 1 minute, during 28 days

Timeline

• Start date: 2008-08-01
• Primary completion: 2012-07-01
• Completion: 2012-08-01
• First posted: 2012-10-03
• Last updated: 2012-10-03

Locations

2 sites across 1 country: Brazil